Sotalol Hydrochloride

ANDA 75515, held by Sun Pharm Industries. Sotalol Hydrochloride.

As of Nov 15, 2026, ANDA 75515 (Sotalol Hydrochloride), held by Sun Pharm Industries, was first approved by FDA on Oct 15, 2001, with 2 approved supplements and 0 published complete response letters.

First approved: Oct 15, 2001
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Oct 15, 2001	Original application	Approved	Letter

Products

4 strengths and forms


Sotalol Hydrochloride80MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Sotalol Hydrochloride160MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Sotalol Hydrochloride240MG · tablet;oral	Sotalol Hydrochloride	Discontinued
Sotalol Hydrochloride120MG · tablet;oral	Sotalol Hydrochloride	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Aug 6, 2004	Supplement 5Labeling	Approved	None posted
Apr 7, 2003	Supplement 3Labeling	Approved	None posted
Oct 15, 2001	Original application	Approved	Letter

Identifiers

Application: ANDA 75515
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters